Jul 16, 2021, 01:00 by User Not Found

Clinical Research News | The willingness of healthcare authorities to accept external control arms (ECAs) in regulatory submissions depends largely on how and when they are used, according to real-world data (RWD) experts from Merck, Bristol-Myers Squibb, and Ikaika Health who presented at the recent DIA 2021 Global Annual Meeting.

Jul 16, 2021, 01:00 by User Not Found

Clinical Research News | A supply chain strategy that truly puts patients at the center requires a wide variety of trial services, delivered seamlessly. Improved patient access, reliability, customizability—all these things are incompatible with fragmented service and require the central coordination and end-to-end oversight only available from a comprehensive, single-source solutions provider.

Jul 15, 2021, 01:00 by User Not Found

Clinical Research News | Changes required of study sites during the COVID-19 pandemic, and their evolving role in the clinical trial ecosystem, was the subject of a panel discussion at the recent DIA 2021 Global Annual Meeting. The need to give sites greater flexibility and respect—and for industry to collaborate to reduce the burden of studies on patients and sites and deal with Europe’s new data protection law—were among the main points of consensus.

Jul 14, 2021, 12:23 by

BioIVT’s new blood donor center is located in White City, a biotech hub, together with cell therapy, gene therapy, and pharmaceutical companies.

Jul 14, 2021, 12:23 by

Thermo Fisher Scientific today announced their collaboration with the UC Davis West Coast Metabolomics Center to form The Center of Excellence in Clinical Metabolomics.

Jul 14, 2021, 12:23 by

Flywheel and Healthmyne: Combined technology solution to accelerate radiomics research and clinical trial outcomes

Jul 14, 2021, 12:23 by

Jul 14, 2021, 12:23 by

Jul 14, 2021, 12:23 by

Jul 14, 2021, 12:22 by

Rho, a full-service contract research organization (CRO) with a proven track record of drug development success, today announced it is coordinating a study called Systemic Allergic Reactions to SARS-CoV-2 Vaccination to assess the proportion of participants with a systemic allergic reaction to the Pfizer-BioNTech and Moderna COVID-19 vaccines in populations at high risk for allergic reaction compared to a general population. This research will be important for further understanding potential risk factors for an allergic reaction to these particular vaccines, as well as to future vaccines that similarly use an mRNA nanoparticle platform. The study is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

Jul 14, 2021, 12:22 by

Acquisition Enriches WCG’s Scientific and Regulatory Capabilities with Comprehensive Services Ensuring Quality and Validity of Clinical Trial Results Across Drug, Medical Device and Artificial Intelligence Studies

Jul 14, 2021, 12:22 by

These new programs will ensure that healthcare organizations are better prepared to handle security threats, and power, water/waste management or supply chain disruptions.

Jul 14, 2021, 11:06 by User Not Found

Clinical Research News | A panel of experts offered their insights on how to “fill the gaps” when it comes to diversity and inclusion in clinical trials at the recent DIA 2021 Global Annual Meeting. The lively and informative session was moderated by Clare Grace, chief patient officer at Parexel, filling the first such role in the CRO industry.

Jul 14, 2021, 09:26 by User Not Found

Clinical Research News | Ensuring patient engagement methodologies are “fit for purpose” from the beginning was the topic of conversation among experts from Europe and the U.S. during the recent DIA 2021 Global Annual Meeting. The manner of engagement directly influences the quality of data collected.

Jul 13, 2021, 01:00 by User Not Found

Clinical Research News | A team of regulatory experts presented at the recent DIA 2021 Global Annual Meeting on COVID-19 real-world data (RWD) analysis and vaccine surveillance. Representatives from the U.S. Food and Drug Administration (FDA) covered the COVID-19 Evidence Accelerator, National COVID Cohort Collaborative (N3C) Data Enclave, and a study describing ethnic and racial disparities in COVID-related hospitalizations, while those from the Danish Medicines Agency focused on COVID-19 cohort data analysis related to post-infection complications and vaccine safety.

Jul 13, 2021, 01:00 by User Not Found

Clinical Research News | Misinformation is not a new concept, but it covers a lot of territory and can be tricky to combat, according to experts participating in a panel discussion on the topic at the recent DIA 2021 Global Annual Meeting. Intentional misinformation, sometimes termed “disinformation,” can be viewed as distinct from the larger body of misinformation that is unintentionally wrong or misleading but nonetheless contributes to poor decision-making.

Jul 12, 2021, 13:49 by User Not Found

Clinical Research News | At his opening keynote address at the recent DIA 2021 Global Annual Meeting, newly retired Merck CEO Kenneth Frazier focused on the “durable innovations” predating the COVID-19 pandemic as well as those with staying power that have emerged over the past 18 months.

Jul 12, 2021, 12:00 by User Not Found

Clinical Research News | Monroe Carell Jr. Children's Hospital at Vanderbilt has responded to the growing incidence of hospital-associated venous thromboembolism (blood clots) in kids by developing an algorithm to predict patients who are at high-risk in real time. A pragmatic clinical trial underway now is testing the effectiveness of a newly validated, general pediatric predictive model.

Jul 8, 2021, 01:00 by User Not Found

Clinical Research News | In at least two, placebo-controlled randomized trials getting underway in the next year, participants will be purposefully infected with a strain of group A streptococcus (Strep A) causing acute pharyngitis (strep throat) in a human challenge test of candidate vaccines intended to confer protection.

Jul 7, 2021, 01:00 by User Not Found

Clinical Research News | When new drugs, vaccines, and medical devices are developed and enter the market, one of the most important things to address is safety. The secret weapon in this data battle is automation and artificial intelligence (AI).